2023-08-01 19:20:13
The Beyfortus antibody, developed by the French pharmaceutical group Sanofi alongside the British laboratory AstraZeneca, should be available in France from September in pharmacies and in health establishments.
The High Authority for Health (HAS) issued a favorable opinion on Tuesday for the management of a preventive treatment against bronchiolitis for infants in France, who will therefore be able to benefit from it from September.
The Beyfortus antibody, developed by the French pharmaceutical group Sanofi alongside the British laboratory AstraZeneca, is one of the therapeutic options in the prevention of respiratory tract infections due to respiratory syncytial virus (RSV) in newborns and infants during of their first exposure to this virus, estimated the Transparency Commission of the High Authority for Health (HAS).
The RSV respiratory virus is best known for the scourge of bronchiolitis it causes every winter. The Directorate General for Health indicated last week that in the event of a favorable opinion from the HAS, pharmacies will be able to order the treatment made available by the State “without invoicing patients”.
“A partial response to the identified medical need”
The HAS considers, however, that Beyfortus provides “a partial response to the identified medical need” because there is not yet any data which makes it possible to “support a possible impact of Beyfortus” on the duration of hospitalization, the transfer to a unit of intensive care or resuscitation, and mortality.
The Commission thus announces that it will “reassess the medicinal product” in the light of any new data available within a maximum period of one year from the date of this opinion.
Beyfortus had obtained marketing authorization from the European Medicines Agency in the fall of 2022. It also received the green light from the United States Medicines Agency (FDA) last month.
Thousands of sick children each year
In France, it is estimated that bronchiolitis affects nearly 30% of infants under the age of two each winter, which represents approximately 480,000 cases per year, recalls the HAS.
This pathology only rarely requires hospitalization: 2 to 5% of infants under the age of one are hospitalized for RSV bronchiolitis each year, or approximately 30,000 children in France.
For children born during the epidemic season, between October and March, the injection of Beyfortus can be administered by the medical team before leaving the maternity ward, specifies Sanofi. If it could not be done in the maternity ward, a catch-up can be done in town during a pediatric visit.
For children under the age of one born before the epidemic season, Beyfortus will be available in pharmacies on prescription from a general practitioner or pediatrician who can then administer it to the child.
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